“Use of these tests may cause serious adverse health consequences or death,” the FDA says.
According to the FDA, the test, manufactured by Australian company Ellume, is supposed to “detect proteins from the SARS-CoV-2 virus from a nasal sample in people two years of age or older…and uses an analyzer that connects with a smartphone app to show users how to perform the test and understand the test results.”
A spokesperson for Ellume says they have the issue under control.
“Ellume has investigated the issue, identified the root cause, implemented additional controls, and we are already producing and shipping new product to the U.S.,” said a spokesperson.
“Importantly, not all of the positive results of the affected tests were false positives, and negative results were not affected by this issue.”